Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen… recallZ-1879-2017 · Arrow International Inc · initiated Mar 17, 2017
Class II Terminated All recalls posted in April 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
FDA root cause category: Process control
What the company is doing
Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to [email protected] or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990.
Recall details
- Recall number
- Z-1879-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 17, 2017
- Posted by the FDA
- Apr 10, 2017
- Recalling firm
- Arrow International Inc
- Quantity
- 310 units
- Product code
- FOZ
- FDA submissions
- K071538
- Distribution
- US Distribution to NJ, IL, and PA
Product description
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
Code information (models, lots, serial numbers)
Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM Lot # 13F16L0105, 23F16K0180 and 13F16L0199
Other devices under the same FDA submission
231 devices cleared under K071538 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN038522Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls1 report
- ARROW IPN931283Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN931284Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN931286Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN036445Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls8 reports
- ARROW IPN915628Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls5 reports
- ARROW IPN915630Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls2 reports
- ARROW IPN036474Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 report
- ARROW IPN904896Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 report
- ARROW IPN038523Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN055818Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN055820Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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